VALBENAZINE TOSYLATE - Generic Drug Details

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What are the generic drug sources for valbenazine tosylate and what is the scope of patent protection?

Valbenazine tosylate is the generic ingredient in three branded drugs marketed by Neurocrine, Lupin Ltd, and Zydus, and is included in four NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Valbenazine tosylate has two hundred and twelve patent family members in thirty-three countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for VALBENAZINE TOSYLATE

International Patents:	212
US Patents:	22
Tradenames:	3
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	38
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALBENAZINE TOSYLATE
DailyMed Link:	VALBENAZINE TOSYLATE at DailyMed

Generic filers with tentative approvals for VALBENAZINE TOSYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	80MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	40MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 60MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for VALBENAZINE TOSYLATE

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VALBENAZINE TOSYLATE

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for VALBENAZINE TOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for VALBENAZINE TOSYLATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for VALBENAZINE TOSYLATE

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Country	Patent Number	Title	Estimated Expiration
Japan	2022544711	特定のＶＭＡＴ２阻害剤を重度腎障害の患者に投与するための方法	⤷ Sign Up
Australia	2017395700	Methods for the administration of certain VMAT2 inhibitors	⤷ Sign Up
Serbia	65154	SOLI VALBENAZIN DIHIDROHLORIDA I NJIHOVI POLIMORFI (VALBENAZINE DIHYDROCHLORIDE SALTS AND POLYMORPHS THEREOF)	⤷ Sign Up
Canada	3149033	PROCEDES D'ADMINISTRATION DE CERTAINS INHIBITEURS DE VMAT2 A DES PATIENTS PRESENTANT UNE INSUFFISANCE RENALE GRAVE (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)	⤷ Sign Up
Croatia	P20210469		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018140096		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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